Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID06040203

Leukocyte-rich PRP or Leukocyte-free PRP vs Placebo in the Treatment of Epicondylitis: a Randomized Controlled Clinical Trial

Led by Istituto Ortopedico Rizzoli · Updated on 2025-09-29

240

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to assess the clinical outcomes of echo-guided injections using platelet-rich plasma (PRP) with different leukocyte levels compared to saline injections for treating patients with elbow epicondylitis who have not improved with conservative therapy. The study is a double-blind, randomized controlled trial designed to evaluate the effectiveness and safety of these injection procedures by tracking improvements and any adverse events after treatment. Participants will be randomly assigned to one of three groups: a single injection of leukocyte-rich PRP, leukocyte-poor PRP, or a saline placebo injection, all guided by ultrasound to the affected elbow area. Before treatment, blood will be drawn to prepare the autologous PRP, with leukocytes filtered out for the leukocyte-poor group. Patients in the saline group may receive PRP treatment after six months if needed. Each participant will receive one injection and may have access to a second injection if no benefit is observed after six months. Participants will be evaluated before treatment and at 1, 3, 6, and 12 months after injection through clinical examinations and questionnaires. Assessments include various patient-rated scores measuring pain, disability, activity level, and overall health. Adverse events, swelling, pain duration, and any medications taken will be recorded throughout follow-up visits. The primary outcome measure is the Patient-rated Tennis Elbow Evaluation at six months, with several secondary assessments conducted at multiple time points.

CONDITIONS

Brief Title

Leukocyte-rich PRP or Leukocyte-free PRP vs Placebo in the Treatment of Epicondylitis

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with a clinical diagnosis of epicondylitis of the elbow
  • Symptoms lasting more than 3 months
  • Ultrasound showing short or long radial extensor carpal tendinopathy
  • Age between 18 and 65 years
  • Both sexes eligible
  • No improvement after at least 3 months of conservative treatment
  • Hemoglobin level greater than 11 g/dl
  • Platelet count greater than 150,000 per mm3
  • Negative serological tests for HBsAg, HCV Ab, and HIV-1-2 Ab
  • No significant electrocardiographic changes
  • Ability and consent to participate in clinical follow-up
  • Signed informed consent form
Not Eligible

You will not qualify if you...

  • Previous surgical treatment on the epicondylar tendons
  • Epicondylar infiltration in the previous 6 months
  • Inability to participate in clinical follow-up
  • Incapacitated patients
  • Immunodepression states
  • Fibromyalgia
  • Ongoing systemic inflammatory diseases (unless stabilized)
  • Uncontrolled thyroid metabolic disorders
  • Alcohol, drug, or medication abuse
  • Use of NSAIDs within 3 days before blood collection
  • Coagulation problems or ongoing antiplatelet therapy that can't be stopped 3 days before blood draw
  • Cardiovascular disease contraindicating a 300-mL blood draw
  • Positive serological tests for HBsAg, HCV Ab, or HIV-1-2 Ab
  • Other current elbow diseases such as osteoarthritis, epitrochleitis, or stiff elbow

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single treatment visit

Participants receive a single echo-guided injection of either leukocyte-rich PRP, leukocyte-poor PRP, or saline solution in the elbow affected by epicondylitis according to randomization.

1 treatment visit (in-person)

Follow-up

Duration - 12 months

Participants are clinically evaluated before treatment and at 1, 3, 6, and 12 months after the injection. Questionnaires and assessments are done to monitor pain, function, and any adverse events.

5 visits (in-person) including baseline and follow-ups at 1, 3, 6, and 12 months

Trial Site Locations

Total: 1 location

1

Istituto Ortopedico Rizzoli

Bologna, Italy, 40136

Actively Recruiting

Loading map...

Research Team

E

Enrico Guerra, MD

R

Roberta Licciardi, MSc

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

3

Similar Trials

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

The Efficacy of Platelet-Rich Plasma on Tendon and Ligament Healing: A Systematic Review and Meta-analysis With Bias Assessment.

Xiao Chen, Ian A Jones, Caron Park...

https://pubmed.ncbi.nlm.nih.gov/29268037

Platelet-rich plasma versus open surgical release in chronic tennis elbow: A retrospective comparative study.

Mert Karaduman, Mustafa Caner Okkaoglu, Hakan Sesen...

https://pubmed.ncbi.nlm.nih.gov/26955228